Bicycle's Zelenectide Pevedotin Shows Positive Phase 2 Data in Urothelial Cancer

Bicycle Therapeutics announced positive initial data from its randomized Phase 2 Duravelo-2 trial and updated Phase 1 Duravelo-1 data for zelenectide pevedotin (formerly BT8009) in patients with metastatic urothelial cancer (mUC). In Duravelo-2, the optimal 6mg dose in combination with pembrolizumab achieved a confirmed overall response rate (ORR) of 58% (increasing to 62% post-cutoff) in previously untreated mUC patients. As a monotherapy in previously treated patients, the confirmed ORR was 30%. Notably, the drug demonstrated a potentially superior safety profile compared to current standards of care, with significantly lower rates of skin reactions and peripheral neuropathy. Updated Phase 1 Duravelo-1 data for untreated, cisplatin-ineligible patients showed a median progression-free survival (PFS) of 13.0 months when combined with pembrolizumab. The company reported that only one patient at the optimal dose discontinued treatment due to a drug-related adverse event. Full results from the randomized Phase 2 portion of Duravelo-2 are expected in the second half of 2026.